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CompletedNCT05814081Updated Apr 14, 2023

How To Prevent Ventilator-Related Lung Damage in Intraoperative Mechanical Ventilation? Pcv or Vcv ?

An observational study in Ventilator-Induced Lung Injury, Ventilator Lung and Mechanical Ventilation Complication, sponsored by Başakşehir Çam & Sakura City Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-04-14.

Sponsored by Başakşehir Çam & Sakura City Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Introduction: Intraoperative Mechanical Ventilation practices can lead to ventilator-associated lung injury (VILI) and postoperative pulmonary complications in healthy lungs. Mechanical Power has been developed as a new concept in reducing the risk of postoperative pulmonary complications as it takes into account all respiratory mechanics that cause VILI formation. Volume control mode is at the forefront in the old anesthesia devices used in the operating room, and today, together with technology, there are anesthesia devices with many modes and features, as in intensive care units. This causes confusion in the use of mechanical ventilators. In this study, volume and pressure control ventilation modes were compared in terms of respiratory mechanics (including mechanical power) in patients operated in the supine and prone positions.

Aim of study: It has been compared the effects on postoperative pulmonary complications (PPH) in terms of VILI risk by calculating mechanical power from advanced respiratory mechanics of patients ventilated in pressure and volume control modes, which are frequently used in operating room applications.

Conclusion: There was no statistically significant difference between the groups in terms of demographic data, ariscat score, and ariscat risk group values. The supine and prone mechanical power (MPrs) values of the volume control group were statistically significantly lower than the pressure control group. P values were calculated as 0.012 and 0.001, respectively.

Results: Supine and prone MPrs values of the volume control group were calculated significantly lower than the pressure control group. Pressure-controlled intraoperative mechanical ventilation is considered to be disadvantageous in terms of the risk of VILI in the supine and prone position in terms of the current mechanical power concept.

Read the detailed description

Although mechanical ventilation is a life-saving intervention, it can lead to ventilator-induced lung injury (VILI). VILI is the damage caused by positive pressure ventilation that starts with the use of mechanical ventilators. There are many factors that cause VILI such as tidal volume, drive pressure, flow, respiratory rate, and PEEP. Mechanical power, which collects these different variables in a single parameter, offers us new possibilities in predicting VILI at the bedside. The mechanical power being above a certain threshold causes damage ranging from pulmonary parenchymal rupture to severe inflammation and edema. Also, higher mechanical power values are associated with higher mortality. The protective ventilation strategy in intensive care units is also applied in operating rooms (OR) to minimize the risk of postoperative pulmonary complications due to VILI. While the volume control mode was at the forefront in the old anesthesia devices used in the OR, today there are anesthesia devices with many modes and features, as in intensive care units. This causes confusion in the use of mechanical ventilators in the perioperative period. Therefore, in this study, the investigators compared the perioperative mechanical power values in prone and supine positions, and postoperative pulmonary complications of two ventilation modes (volume control-pressure control ventilation). Thus, the investigators aimed to find out which ventilation mode would be advantageous in the perioperative period.

02

Conditions studied

  • Ventilator-Induced Lung Injury
  • Ventilator Lung
  • Mechanical Ventilation Complication
  • Postoperative Complications

Keywords

  • mechanical power
  • prone
  • supine
  • postoperative pulmonary complications
03

In context

Lung Injury

399 studies on the registry are indexed under Lung Injury; 50 are open to participants now.

This study's enrollment of 80 is above the median of 70 across 136 observational studies indexed under Lung Injury.

Browse Lung Injury studies →

Lead sponsor

Başakşehir Çam & Sakura City Hospital is the lead sponsor of 105 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Cervical hernia, lumbar hernia and lumbar stabilization cases who were operated in the neurosurgery operating room of the anesthesia and reanimation clinic were examined.

Inclusion criteria

  • ASA I - III risk group patients
  • Patients between the ages of 18-70
  • At least 2 hours of mechanical ventilation time

Exclusion criteria

Exclusion Criteria:

  • Patients with COPD or Asthma bronchial
  • Patients with a functional capacity of less than 7 METS
  • Pregnant and lactating female patients.
  • Patients who have had thoracic surgery before
  • Patients with BMI above 35
  • Patients who had hemodynamic instability or desaturation (SpO2\<92%) during the operation
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Pressure Control Ventilation Supine Group

    20 patients were ventilated in the supine position with pressure control mode.

    Procedure: Position/Ventilation

  • Pressure Control Ventilation Prone Group

    20 patients were ventilated in the prone position with pressure control mode.

    Procedure: Position/Ventilation

  • Volume Control Ventilation Supine Group

    20 patients were ventilated in the supine position with volume control mode.

    Procedure: Position/Ventilation

  • Volume Control Ventilation Prone Group

    20 patients were ventilated in the prone position with volume control mode.

    Procedure: Position/Ventilation

Interventions

  • ProcedurePosition/Ventilation

    Positioning and ventilation mode adjustments were made to the patients.

06

What researchers measure

Primary outcomes

  1. Mechanical power

    Mechanical power values calculated during surgery were compared.

    Time frame: During surgery (2 hours to 4 hours)

  2. Postoperative complications

    Postoperative pulmonary complications were observed.

    Time frame: Postoperative period (up to 10 days)

Secondary outcomes

  1. Respiratory parameters other than mechanical power

    PEEP(mmHg) value measured during surgery were compared.

    Time frame: During surgery (2 hours to 4 hours)

  2. Respiratory parameters other than mechanical power

    Tidal volume(ml) value measured during surgery were compared.

    Time frame: During surgery (2 hours to 4 hours)

  3. Respiratory parameters other than mechanical power

    Peak pressure(mmHg) value measured during surgery were compared.

    Time frame: During surgery (2 hours to 4 hours)

  4. Respiratory parameters other than mechanical power

    Plato pressure(mmHg) value measured during surgery were compared.

    Time frame: During surgery (2 hours to 4 hours)

  5. Respiratory parameters other than mechanical power

    Driving pressure(mmHg) value measured during surgery were compared.

    Time frame: During surgery (2 hours to 4 hours)

  6. Respiratory parameters other than mechanical power

    Inspiratory time(second) value measured during surgery were compared.

    Time frame: During surgery (2 hours to 4 hours)

07

Study locations

1 site
  • Basaksehir Cam Sakura City Hospital
    Istanbul, Turkey
08

References and documents

Publications

  • Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available. Erratum In: N Engl J Med. 2014 Apr 24;370(17):1668-9. PubMed 24283226 ↗
  • Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056. PubMed 26872367 ↗
  • Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12. PubMed 27620287 ↗
  • Tonetti T, Vasques F, Rapetti F, Maiolo G, Collino F, Romitti F, Camporota L, Cressoni M, Cadringher P, Quintel M, Gattinoni L. Driving pressure and mechanical power: new targets for VILI prevention. Ann Transl Med. 2017 Jul;5(14):286. doi: 10.21037/atm.2017.07.08. PubMed 28828361 ↗
  • Giosa L, Busana M, Pasticci I, Bonifazi M, Macri MM, Romitti F, Vassalli F, Chiumello D, Quintel M, Marini JJ, Gattinoni L. Mechanical power at a glance: a simple surrogate for volume-controlled ventilation. Intensive Care Med Exp. 2019 Nov 27;7(1):61. doi: 10.1186/s40635-019-0276-8. PubMed 31773328 ↗
  • Asar S, Acicbe O, Cukurova Z, Hergunsel GO, Canan E, Cakar N. Bedside dynamic calculation of mechanical power: A validation study. J Crit Care. 2020 Apr;56:167-170. doi: 10.1016/j.jcrc.2019.12.027. Epub 2020 Jan 2. PubMed 31931417 ↗

Individual participant data

Plan to share: Undecided — Not decided yet.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05814081
Lead sponsor
Başakşehir Çam & Sakura City Hospital
Responsible party
Furkan Tontu (Anesthesiologist, Anesthesiology and Reanimation Department, Principal Investigator, Başakşehir Çam & Sakura City Hospital) — Principal investigator
First posted
Apr 14, 2023
Start date
Jan 1, 2021
Primary completion
May 1, 2021
Completion
Jun 1, 2021
Last update
Apr 14, 2023

Study contacts

Furkan Tontu
study director · Basaksehir Cam & Sakura City Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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